Phase 4 Completed N=20 Randomized Quadruple-blind Treatment

Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00754546 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcomePrimary: Exercise Endurance Time — 490; 333; 472; 362 seconds — p=< 0.05

Summary

Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.

Outcome Measures

Outcome	Result	p-value
PRIMARY Exercise Endurance Time	490; 333; 472; 362	< 0.05 sig
SECONDARY Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise	1.27; 1.79; 1.42; 1.49	—

Eligibility Criteria

Inclusion Criteria

male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of < 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.

Exclusion Criteria

any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing

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Data sourced from ClinicalTrials.gov (NCT00754546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.